Medical product package

ABSTRACT

A catheter and package combination including a package having opposed front and rear panels that are sealed together to define a sealed interior cavity. The package also has top and bottom edges and opposed side edges. The cavity has a first height extending in a direction between the top and bottom edges. The front and rear panels are configured to tear adjacent to one of the side edges in the direction between the top and bottom edges to form an opening in communication with the cavity wherein the opening has a second height in the direction between the top and bottom edges that is smaller than the first height of the cavity. A urinary catheter in a compact configuration is disposed within the cavity.

FIELD OF THE DISCLOSURE

The present disclosure is generally related to compact medical productpackaging and, more particularly, to compact urinary catheter packaging.

BACKGROUND

Catheters are used to treat many different types of medical conditionsand typically include an elongated catheter tube that is inserted intoand through a passageway or lumen of the body. Urinary catheters, and inparticular intermittent urinary catheters, are a good option for thosewho suffer from various abnormalities of the urinary system, such asurinary incontinence. With the advent of intermittent urinary catheters,individuals with urinary system abnormalities can convenientlyself-catheterize to drain the individual's bladder.

Individuals who use intermittent urinary catheters typically use severalsingle-use, individually packaged, sterile ready-to-use catheters everyday. Oftentimes, such use occurs outside the home and in publicrestrooms. When outside of the home, intermittent catheter users mustcarry a supply of the single-use, ready-to-use catheters. Existingcatheters, particularly for male users, have considerable length, whichis typically between 30 cm (12 inches) and 40 cm (16 inches). Manycommercially available single-use catheters are packaged in an elongatedcondition wherein the catheter package containing the catheter isrelatively narrow and long. Such packages extend beyond the length ofthe catheter and can be up to about 48 cm (19 inches) in length.

A desired criterion for single-use, ready-to-use catheters is that thepackaging be user-friendly. Carrying and transporting such elongatedpackages while outside of the home may be awkward and may make the useruncomfortable, especially for those who desire to be discreet.Additionally, users that have trouble with dexterity may find itdifficult to handle and open such elongated packages. Therefore, theexisting catheter packaging may not be ideal for some users in that suchpackaging may be difficult to store and carry, more conspicuous thansome users would prefer, and hard to handle and open for those who havetrouble with dexterity.

SUMMARY

There are several aspects of the present subject matter which may beembodied separately or together in the devices and systems described andclaimed below. These aspects may be employed alone or in combinationwith other aspects of the subject matter described herein, and thedescription of these aspects together is not intended to preclude theuse of these aspects separately or the claiming of such aspectsseparately or in different combinations as set forth in the claimsappended hereto.

In one aspect, a catheter and package combination including a generallyrectangular package having opposed front and rear panels that are sealedtogether to define a sealed interior cavity. The package has top andbottom edges and opposed side edges. The cavity has a first heightextending in a direction between the top and bottom edges. The front andrear panels are configured to tear adjacent to one of the side edges inthe direction between the top and bottom edges to form an opening incommunication with the cavity. The opening has a second height in thedirection between the top and bottom edges that is smaller than thefirst height of the cavity. A urinary catheter in a compactconfiguration is disposed within the cavity.

In another aspect, a catheter and package combination includes a packagehaving opposed front and rear panels that are sealed together to definea sealed interior cavity. The package has top and bottom edges andopposed side edges. The cavity includes a first portion that has a firstheight extending in a direction between the top and the bottom edges,and the cavity includes a second portion that has a second heightextending in the direction between the top and bottom edge wherein thesecond height is shorter than the first height. The front and rearpanels are configured to tear in the direction between the top andbottom edges to form an opening in communication with the second portionof the cavity. A urinary catheter in a compact configuration is disposedwithin the cavity.

In a further aspect, a catheter and package combination includes apackage having opposed front and rear panels that are sealed together todefine a sealed interior cavity. The package has top and bottom edgesand opposed side edges. The cavity includes a first portion that has afirst height extending in a direction between the top and the bottomedges, and the cavity includes a second portion that has a second heightextending in the direction between the top and bottom edges wherein thesecond height is shorter than the first height. A catheter in a coiledconfiguration is disposed within the cavity wherein the catheter has ahydrophilic surface. An amount of liquid is disposed within the cavityfor hydrating the hydrophilic surface of the catheter. The front andrear panels include a directional tear element that propagates tearingof the panels along a desired line in the direction between the top andbottom edges to form an opening in communication with the second portionof the cavity. The opening has a third height in the direction betweenthe top and bottom edges wherein the third height is shorter than thefirst height. The package also includes a tear initiation element forinitiating tearing of the front and back panels.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of one embodiment of a medicalproduct package of the present disclosure;

FIG. 2 is a rear perspective view of the package of FIG. 1;

FIG. 3 is a front elevational view of the package of FIG. 1 shown with acatheter in a compact configuration within the package;

FIG. 4 is a plan view of the catheter of FIG. 3 shown in an elongatedconfiguration;

FIG. 5 is a cross-sectional view of the package of FIG. 3 taken alonglines 5-5;

FIG. 6 is a front perspective view of the package of FIG. 1 shown in anopen configuration;

FIG. 7 is a rear perspective view of the package of FIG. 1 shown in anopen configuration;

FIGS. 8-10 are cross-sectional views of alternative embodiments of themedical package of the present disclosure;

FIG. 11 is a front elevational view of another embodiment of a medicalpackage of the present disclosure;

FIG. 12 is a front elevational view of another embodiment of a medicalpackage of the present disclosure;

FIG. 13 is a perspective view of the packaging of FIG. 11 shown in anopened configuration;

FIG. 14 is a perspective view of another embodiment of a catheterassembly of the present disclosure;

FIG. 15 is a front elevational view of the package of FIG. 1 shown withthe catheter assembly of FIG. 14 in a compact configuration within thepackage;

FIG. 16 is a front perspective view of another embodiment of a medicalproduct package of the present disclosure; and

FIGS. 17-21 are cross-sectional views of films that may be used to forma medical product package in accordance with the present disclosure.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The embodiments disclosed herein are for the purpose of providing adescription of the present subject matter, and it is understood that thesubject matter may be embodied in various other forms and combinationsnot shown in detail. Therefore, specific embodiments and featuresdisclosed herein are not to be interpreted as limiting the subjectmatter as defined in the accompanying claims.

FIGS. 1-3 illustrate one embodiment of a package 10 for containing amedical product. Package 10 is described herein as packaging for aurinary catheter; however, package 10 also may be used as packaging forother medical products as well. Package 10 is particularly useful incompact packaging of elongated medical products that can be coiled,folded, curved or bent into a compact configuration for placement withinthe package 10.

Package 10 is preferably liquid and gas impermeable and may be made fromany suitable liquid and gas impermeable materials, such as foils,polymers or multilayer films or laminates containing layers of metallicand/or polymer materials. In one embodiment, the package is made fromaluminum foil. In another embodiment, the package is made from a polymerfilm. In yet another embodiment the package is made from a multilayeredfilm including a polymer overlaying a foil, such as polypropylenecovered aluminum foil. When the package is made entirely of polymers ora polymer covered foil, the polymer may be, for example, one or more ofpolypropylene, polyethylene, polyamide, polyester, polyurethane,ethylene-vinyl acetate, polychlorotrifluoroethylene and co-polymersthereof. As explained in more detail with respect to FIGS. 16-21 suchpolymers may be oriented (aligned) polymers. The oriented polymers mayinclude, for example, monoaxially oriented polypropylene (MOPP) orbiaxially oriented polypropylene (BOPP), oriented polyamide (OPA),monoaxially or biaxially oriented polyester, monoaxially or biaxiallyoriented polyurethane, monoaxially or biaxially oriented ethylene-vinylacetate, and monoaxially or biaxially orientedpolychlorotrifluoroethylene. In one example, package 10 is made from aSurlyn® resin coated foil supplied by Du Pont. In one embodiment, thepackage 10 is made of a multilayered film including layers ofpolypropylene, polyethylene, aluminum foil and Surlyn. The film mayinclude, for example, a 25.4 μ outer layer of oriented polypropylene,25.4 μ intermediate layer of low density polyethylene, 8.9 μintermediate layer of aluminum foil and 44.4 μ inner layer of Surlyn®.

One benefit of the use of a Surlyn® in the multilayered film is that theSurlyn® resin reduces the noise or crinkle of the package when thepackage is manipulated and handled by the end user during opening of thepackage and removal of its contents. Such noise or crinkle reduction maybe desired by user's that desire discreetness when using the medicalproduct, such as a catheter, in public places.

In the embodiment illustrated in FIGS. 1-3, package 10 is generallyrectangular and may be sized or configured to fit easily within astandard shirt front pocket or within a standard pants back pocket. Thestandard front pocket of a dress shirt has a width of about 100 mm and aheight of about 130 mm and the standard back pocket of a pair of pantshas a height of about 140 mm and a width of about 120 mm. Front shirtpockets and back pants pockets may vary and when package 10 has largerdimensions than that of the shirt or pants pocket, the package maywrinkle or bend to fit within the pocket or may stick slightly out ofthe opening of the pocket. The package also may be shapes other thanrectangle. For example, the package 10 may be generally round (e.g.circular, oval, ellipse, etc.) or generally square.

Referring to FIG. 3, the height H of package 10 may be between about 120mm and about 160 mm and is preferably about 140 mm as measured from topedge 36 to bottom edge 38. The width W of package 10 may be betweenabout 75 mm and about 120 mm and is preferably about 110 mm as measuredfrom side edge 40 to side edge 42. The height to length ratio of package10 may be between about 1.3 to about 2.1 and is preferably about 1.3.The height and width of package 10 may also be larger or smaller thanthe above-mentioned dimensions depending on the intended use.

The package 10 includes an elongated medical product, such as a urinarycatheter 12, disposed in a compact configuration within a cavity 14(FIGS. 3 and 5) of package 10. In the compact configuration, catheter 12may be coiled, folded, curved and/or bent. In FIG. 3, elongated cathetertube 12 is shown in a curved compact configuration and, in particular,in a wound or coiled compact configuration. The catheter 12 may be anysuitable urinary catheter used for bladder drainage. FIG. 4 illustratescatheter 12 in an elongated configuration. In the illustratedembodiment, catheter 12 includes an elongated catheter tube 16 having aproximal insertion end portion 18 and a distal end portion 20.

Catheter 12 also includes one or more drainage eyes or openings 22 at ornear the proximal insertion end 18 of the catheter tube 16 for drainingthe bladder. Catheter 12, optionally, may include a soft, typicallyrubbery introducer tip 24 adjacent proximal end 18 and may, optionally,include an end cap 26 that covers and protects the introducer tip 24. Aconnector or drainage member 28, which may be a funnel, is located atthe distal end 20 of the catheter tube 16.

As explained in more detail below, package 10 may be configured forliquid or vapor hydration of a hydrophilic coated catheter disposedwithin package 10. In such an embodiment, catheter tube 16 includes anouter surface having a hydrophilic coating on at least a portionthereof. The details of such hydrophilic catheters are described in U.S.Pat. No. 8,051,981, which is hereby incorporated herein by reference.The hydrophilic coating of the catheter tube 16 is wetted, hydrated orotherwise activated within the package 10 to result in a highlylubricious condition that eases insertion of catheter 12 into andthrough the urethra.

Catheter 12, optionally, also may include a thin flexible sleeve 30 thatcovers the outer surface of the catheter tube 16. Sleeve 30 may beformed of any variety of thin flexible polymeric film materials, such aspolyethylene, plasticized PVC, polypropylene, polyurethane orelastomeric hydrogels. The user may handle and manipulate catheter tube16 through sleeve 30 which provides a contamination barrier between theuser's hands and catheter tube 16. For example, when catheter 12 isbeing inserted into the urethra, the user grasps and handles cathetertube 16 through the sleeve 30. When catheter tube 16 includes ahydrophilic coating thereon, the sleeve 30 may be liquid and/or vaporpermeable so as to allow liquid and/or vapor therethrough to hydrate thehydrophilic coating while catheter 12 is stored within package 10. Whenpackage 10 is configured for vapor hydration, sleeve 30 is preferablyliquid impermeable and vapor permeable.

FIG. 1 shows a front view of package 10 while FIG. 2 shows a rear view.Package 10 includes a front panel 32 (FIG. 1) and a rear panel 34 (FIG.2), which may be mirror images of each other. Front panel 32 and rearpanel 34 are affixed or peripherally sealed to each other along theiredges to define inner cavity 14 (FIG. 5) for containing a medicalproduct, such as catheter 12 in a compact configuration. Preferably,front panel 32 and rear panel 34 are two separate sheets of material inwhich the confronting edges of front and rear panels 32, 34 areperipherally sealed to form top edge 36, bottom edge 38, opposing sideedges 40, 42 and a corner seal 44. The edges of the front and rearpanels 32, 34 may be sealed by any suitable sealing method which mayinclude, for example, heat and/or adhesive sealing. In the illustratedembodiment, top edge 36 of package 10 is formed by seal 36 a, bottomedge 38 is formed by seal 38 a, side edge 40 is formed by seal 40 a, andside edge 42 is formed by seal 42 a. The peripheral seal along the edgesof package 10 at least substantially forms or defines sealed cavity 14.In the illustrated embodiment, a portion of cavity 14 may be defined bycorner seal 44. Corner seal 44 has a generally rectangular or squareshape and includes two sections, a first seal section 46 that extendsgenerally vertically downward from top edge 36 and a second seal section48 that extends generally horizontally inward from side edge 42.

In an alternative embodiment, front panel 32 and rear panel 34 may bepart of a single sheet (which may be a multilayered film) that is foldedso as to define the front and rear panels 32, 34, where the foldedsection of the sheet defines one of the edges. For example, bottom edge38 shown in FIGS. 1 and 2 may be a fold of the sheet instead of a sealbetween two separate sheets.

Referring to FIG. 1, in the illustrated embodiment, cavity 14 includes afirst portion 50 that has a height X that is greater than a height Y ofa second portion 52. Both heights X and Y are measured in a directionbetween top edge 36 and bottom edge 38 and that is parallel to sideedges 40, 42. As used herein “measured in a direction between top edge36 and bottom edge 38” means the height extends in such direction anddoes not necessary extend all the way to the top and/or bottom edges. Inthe illustrated embodiment, the boundary of first portion 50 is at leastpartially defined by top seal 36 a, side seal 40 a and the first cornerseal section 46. As shown in FIG. 1, height X of portion 50 extendsbetween top sealed 36 a and bottom seal 38 a. The boundary of portion 52is at least partially defined by the second corner seal section 48,bottom seal 38 a and side seal 42 a. Height of portion 52 extendsbetween bottom seal 38 a and the generally horizontally extending secondseal section 48 of corner seal 44. As illustrated in FIG. 3, themajority of catheter 12 in the compact coiled configuration resides infirst portion 50 of cavity 14. In other embodiments heights X and Y mayextend all the way to top and bottom edges 36, 38.

When catheter 12 is a hydrophilic catheter, package 10 may include oneor more sources for hydrating the hydrophilic surface of the catheterwhile the catheter is stored within the package. For example, an amountof liquid for contacting and hydrating the hydrophilic surface of thecatheter 12 may be contained (or provided) within cavity 14 of package10. In an alternative embodiment, an amount of vapor donating liquidthat provides a vapor for vapor hydrating the hydrophilic surface of thecatheter 12 may be disposed within cavity 14.

Referring to FIGS. 3 and 5, when package 10 is configured for vaporhydration of a hydrophilic catheter, the package 10 may include awicking element 54 (best shown in FIG. 5, shown in phantom in FIG. 3)that is disposed on an inner surface 56 of the rear panel 34. Wickingelement 54 also may be disposed on the inner surface of front panel 32.Wicking element 54 may be attached to inner surface 56 by, for example,an adhesive. Alternatively, wicking element 54 may be loosely placed(i.e., not physically attached) within cavity 14 such as against innersurface 56. The wicking element 54 may comprise any suitable wickingmaterial, such as, for example, a fabric, absorbent or an absorbent opencell foam and may be in the form of a strip of such material. Thewicking element 54 is wetted with a vapor donating liquid, such as purewater or an aqueous solution, preferably at a point in time prior towhen the sealed cavity 14 is formed.

Package 10 also includes a gas permeable, liquid impermeable barrier 58(best shown in FIG. 5, shown in phantom in FIG. 3) that covers the innersurface 56 of the panel (34 or 32) against which wicking element 54 isdisposed. The edges 55 of barrier 58 may be, for example, heat sealed toinner surface 56 of rear panel 34 after wicking element 54 has beenwetted with a vapor donating liquid medium. A portion of edge 55 ofbarrier 58 may be sealed to inner surface 56 of the rear panel 34 bybeing positioned between the edges of front panel 32 and rear panel 34and being sealed by seals 36 a, 38 a and 40 a. As illustrated in FIG. 5,edge 55 of barrier 58 is positioned between and captured by confrontingedges of front panel 32 and bottom panel 34 and sealed by seal 40 a.

Referring to FIG. 5, barrier 58 separates sealed cavity 14 into a firstcompartment 60 containing the catheter 12 and a second compartment 62containing the liquid wet wicking element 54 such that the catheter 12is not in direct contact with the vapor donating liquid contained withinsecond compartment 62. The wicking element 54 provides for at leastsubstantially uniform distribution of liquid in compartment 62. As notedabove, the vapor donating liquid is preferably pure water or an aqueoussolution that produces a vapor, preferably water vapor, which results ina vapor atmosphere within the sealed cavity 14. When the vapor is awater vapor, the vapor results in a vapor atmosphere of between 90%-100%relative humidity within cavity 14 and more preferably 100% relativehumidity. The vapor is absorbed by the hydrophilic coating on thecatheter 12 to hydrate or activate the hydrophilic coating.

Packages of the type described herein include an opening element that iseasy to use particularly, by individuals of limited or unequaldexterity. Turning to FIGS. 1-3, front panel 32 includes a firstdirectional tear element, such as tear tape 64, and rear panel 34includes a second directional tear element, such as tear tape 64 a. Teartape 64 overlays outer surface 66 of the front panel 32 and tear tape 64a overlays outer surface 68 of rear panel 34, and each of tear tape 64,64 a extend in a direction between top edge 36 and bottom edge 38. Thedirectional tear tape 64, 64 a may be applied to outer surface 66 offront panel 32 and outer surface 68 of rear panel 34, respectively at oradjacent to edge 42. The tear tape 64, 64 a may be applied before orafter the package 10 has been sealed with catheter 12 disposed therein.Tear tape 64, 64 a includes a plurality of substantially straight,vertically extending alternating ridges 69 and grooves 71. The tear tape64, 64 a and the ridges 69 thereon may extend from top edge 36 to bottomedge 38. In an alternative embodiment tear tape 64, 64 a and/or theridges 69 of the tear tape may only partly extend between top edge 36and bottom edge 38. As will be discussed in further detail below, thetear tape 64, 64 a result in package opening that preferably forms agenerally straight vertically extending opening. Preferably the openingis made along an intended line.

Package 10 may include a tab 70 that can be gripped and pulled to forman opening within package 10 or commence the opening sequence. Tab 70,optionally, may include a gripping element, such as the illustrated pullring or finger hole 72, for ease of gripping and pulling tab 70. Fingerhole 72 extends through front panel 32 and rear panel 34 and may beformed by punching or otherwise cutting out material from front panel 32and rear panel 34. Preferably, finger hole or pull ring 72 is formedafter package 10 has been sealed and tear tape 64 has been applied. Inan alternative embodiment, tab 70 is solid and does not include a fingerhole.

Package 10 also includes a tear line 74 that at least partially definestab 70. The tear line 74 extends downwardly from top edge 36 of package10 and curves in a direction toward side edge 42. When tab 70 includesfinger hole 72, the tear line may curve at least partially around thefinger hole. In any event, the tear line 74 extends to or near tear tape64, 64 a. Tear line 74 may include a downward projecting segment 76 thatextends substantially vertically within the region of tear tape 64, 64 aand in the direction of the grooves or ridges of tape 64, 64 a. Tearline 74 may be a score line or cut line that extends through front panel32 and rear panel 34. When tear line 74 is a cut line that extendsthrough front and rear panels 32, 34, the cut line may be broken up intodiscrete segments separated by intervening attached portions or notches78 that keep tab 72 attached to the package until use.

Turning to FIG. 6, to open package 10, a user may grip tab 70 by fingerhole 72, when one is present, and pull tab 70 forward or backward awayfrom the rest of the package and in a downward direction. In FIG. 6,with the front panel 32 facing the user, tab 70 is pulled backward anddownward and away from the user, as shown by arrow 80. As the user pullstab 70, the package 10 tears along tear line 74 and tear line 74propagates or advances the tear toward directional tear tape 64, 64 a.As the package tears in the region of directional tear tape 64, 64 a,the tear tape causes front and rear panels 32, 34 to tear along adesired line, which in the illustrated embodiment is a substantiallystraight vertical line. In particular, once the tear starts down one ofthe grooves 71 located between the ridges 69, the tape advances the tearalong that particular groove. Tearing of front and rear panels 32, 34results in a substantially straight, clean and uniform vertical opening82 that extends from bottom seal 38 a to corner seal section 48. Theopening has a height Z, as measured in a direction between top edge 36and bottom edge 38 and that is generally parallel with side edge 40,height 2 is smaller than height X of first portion 50. The opening beingsmaller than first portion 50 is beneficial in that the smaller openingtends to keep catheter 12 from inadvertently falling out of package 10upon opening of the package. In this embodiment, the compact coiledconfiguration of catheter 12 has a natural tendency toward uncoiling andexpanding radially outwardly. As such, the coil tends to expand withinand substantially occupy first portion 50. As the second portion 52and/or opening 82 are smaller than the first portion 50, the catheter ismore likely to remain in cavity 14 upon opening. Once the opening 82 iscreated, the user grips and pulls the catheter out of the package 10 foruse.

As illustrated in FIG. 7, because the front and rear panels 32, 34 aremirror images of each other and both have tear tape 64, 64 a inapproximately the same location, the package 10 may be just as easilyopened with rear panel 34 facing the user. The user pulls the tab 70downward and backward from the user, as indicated by arrow 84. Asdiscussed above, oftentimes users of urinary catheters have trouble withdexterity and may have more control of one hand over the other. Whilemost likely unintentional, some of the commercially availableready-to-use catheters are packaged in packaging that tends to be easierto open for either a right handed or left handed individual. In suchinstances, it will be harder for one group of users to open the packageunless the manufacture makes two different package configurations, e.g.,one for right hand dominant individuals and one for left hand dominantindividuals. In general, it is usually more expensive for manufacturesto make two different package configurations and thus most manufacturesopt to make one package. As can be seen by FIGS. 6 and 7, one of thebenefits of package 10 is that the package is equally openable by bothright and left handed individuals. As such package 20 serves most usersand avoids the cost of manufacturing different package configurations,based on the dexterity or the right/left handedness of the users.

FIGS. 8-10 illustrate alternate embodiments of vapor hydrating ahydrophilic catheter within package 10. Many of the features of theseembodiments are substantially similar to those of the previousembodiment and thus carry identical reference numerals for identicalelements. Turning first to FIG. 8, package 10 includes a wicking element54 that is disposed within cavity 14. The wicking element 54 may beaffixed to inner surface 56 of rear panel 34 or may be loosely placedwithin cavity 14. The wicking element 54 is wetted with a vapor donatingliquid that provides a vapor which hydrates the hydrophilic surface oncatheter 12 while the catheter is stored therein.

In FIG. 9, package 10 includes a gas permeable, liquid impermeablebarrier 58 but without wicking element 54. The edges of barrier 58 aresealed to the inner surface 56 of rear panel 34 to form a sealedcompartment 87 which contains a vapor donating liquid 86. The vapordonating liquid 86 provides a vapor that permeates through barrier 56and contacts the hydrophilic surface of catheter 12 to wet the surfacewhile catheter 12 is disposed and stored within cavity 14.

In FIG. 10, package 10 includes one or more sachets 88 disposed incavity 14. Sachet 88 may be attached to inner surface 56 of the rearpanel 34 or may be loosely placed within package 10. Sachet 88 may be atleast partially made from a vapor permeable, liquid impermeable materialand defines a sealed compartment 90 within cavity 14. In the illustratedembodiment, a wicking element 54 is disposed within the sealedcompartment 90 of sachet 88. The wicking element 54 is wetted with avapor donating liquid to provide a vapor that permeates through sachet88 and contacts the hydrophilic surface of catheter 12 to wet thesurface. In an alternative embodiment, wicking element 54 may beeliminated from sachet 88 and sachet 88 may only contain a vapordonating liquid in compartment 90.

FIG. 11 illustrates another embodiment of a package 100 of the presentdisclosure. Package 100 includes a front panel 132 and a rear panel (notshown) that are sealed together to form a sealed cavity that containsurinary catheter 12 in a compact configuration. In this embodiment, thecavity is generally uniform throughout. When the package 100 isconfigured for hydrating a hydrophilic catheter within the package,package 100 and the cavity formed therein may include any of the liquidor vapor hydrating configurations described above and/or shown in FIGS.5 and 8-10.

As with the previously described package 10, package 100 includes adirection tear element, such as a strip of directional tear tape 164vertically extending over front panel 132 and rear panel. Package 100also includes a tear initiation element 174, such as a tear line, notchor slit, extending from top edge 136 to at or near the tear tape 164.The tear initiation element 174 extends through the front and rearpanels and initiates tearing of the package.

Package 200 shown in FIG. 12 is similar to that of FIG. 11 except thatthe package is narrower and it includes a shorter length catheter 12 adisposed within a sealed cavity of the package. Catheter 12 a may havethe same features as catheter 12 disclosed above except that it is muchshorter in length because it is designed to be used by females (who havea much shorter urethra than males). In this embodiment, catheter 12 ahas a compact bent, curved or arcuate configuration when placed withincavity 14. When package 200 is configured for hydration of a hydrophiliccatheter, package 200 and the cavity formed therein may include any ofthe liquid or vapor hydrating configurations described above and/orshown in FIGS. 5 and 8-10. Similar to package 100, package 200 includestear tape 264 extending over a portion of each of the front panel 232and rear panel (not shown). Package 200 also includes a tear initiationelement 274, such as a tear line, notch or slit that extends from topedge 236 to at or near tear tape 264.

Packages 100 and 200 may be opened in similar fashion and such openingis now described in relation to package 100. Referring to FIG. 13,package 100 may be opened by gripping corner 144 of the package andpulling the corner downward and away from the package 100. The tearinitiation element 174 propagates or advances the tear in or toward thetear tape 164 and into one of the grooves 171 (FIG. 11) of the tear tape164. As the user pulls the corner 144, the package 100 tears down theone of the grooves 171 and in a substantially straight line to form asubstantially straight opening 182.

FIGS. 14 and 15 illustrate another embodiment of a catheter package ofthe present disclosure. As illustrated in FIG. 14, the catheter assembly11 includes catheter 12 b having similar features to catheter 12described above. In this embodiment, catheter 12 b includes a connectionmember 28 b at the distal end portion 20 b thereof that is attached to acollection bag 15. Referring to FIG. 15, package 10 a is substantiallyidentical to the package shown in FIGS. 1-10. In the compactconfiguration, catheter 12 b is coiled and collection bag 15 is in afolded configuration. A restraining member 17, such as a band andpreferably a paper band, retains the collection bag 15 in the foldedconfiguration. As illustrated, the catheter 12 b in the coiled compactconfiguration substantially resides in portion 50 a while collection bagresides in the second portion 52 a of cavity 14.

FIG. 16 illustrates another embodiment of a package 300 of the presentdisclosure. Package 300 is substantially similar to that of package 10except that the directional tear element comprises an oriented polymerfilm in which high linear molecular orientation in one direction isprovided and molecular orientation in another direction perpendicular tothe one direction is extremely low. The higher side molecularorientation is directed in parallel and coincides with a desired tearingdirection. In the illustrated embodiment, package 300 includes a frontpanel 332 and a rear panel (not shown). The front panel 332 and rearpanel are made from a film that includes an oriented polymer wherein thehigh linear molecular orientation of the polymer is in parallel withtearing direction T for facilitating tearing of the front panel 332 andrear panel (not shown) in the tearing direction along line 304 (shown inphantom) of package 300.

The oriented polymers may include monoaxial and biaxial orientedpolymers. Such polymers may include, for example, MOPP, BOPP, OPA,monoaxially or biaxially oriented polyester, monoaxially or biaxiallyoriented polyurethane, monoaxially or biaxially oriented ethylene-vinylacetate, and monoaxially or biaxially orientedpolychlorotrifluoroethylene.

FIGS. 17-21 illustrate different films from which package 300 may bemade. Referring to FIG. 17, packaging film 306 may include a singlelayer of a liquid and gas impermeable oriented polymer havingdirectional tear properties wherein surface 307 of film 306 serves asthe outer surface of the package, as surface 309 servers as the innersurface of the package.

Turning to FIG. 18, a multilayered packaging film 308 has three layersincluding a first layer 310 of an oriented polymer which includesdirectional tear properties. The layer 310 has an outer surface 311 thatwill serve as the outer surface of the package. A second adhesive layer314 is interposed between first layer 310 and a third layer 312 whereinthe adhesive layer 314 bonds the first and third layers 310, 312. Thethird layer 312 is a polymer layer and has a surface 313 that serves asthe inner surface of the package. At least one of the polymers of thefirst and second layers 310, 312 is comprised of a liquid and gasimpermeable polymer.

FIG. 19 illustrates an alternative embodiment of a multilayeredpackaging film 316 which as three layers including an outer foil layer318 which has an outer surface 317 that will serve as the outer surfaceof the package. Foil layer 318 may be, for example, a layer of aluminumfoil. A second adhesive layer 322 is interposed between the first layer318 and a third layer 320 of an oriented polymer having directional tearproperties. The second adhesive layer 322 bonds the first and thirdlayers 318, 320. Third layer 320 has a surface 319 which will serve asthe inner surface of the package.

In the embodiment illustrated in FIG. 20, a multilayer packaging film324 has five layers including a first layer 326 of oriented polymerwhich has directional tear properties. The first layer 326 has an outersurface 323 that will serve as the outer layer of the package. A secondlayer 330 of adhesive is interposed between first layer 326 and a thirdlayer 328 of foil. A forth layer 334 comprising an adhesive isinterposed between the third layer 328 and a fifth layer 333 which iscomprised of a polymer. The polymer of the fifth layer 333 may be anoriented or a non-aligned polymer. Surface 325 of fifth layer 333 willserve as the inner surface of the package.

In the embodiment illustrated in FIG. 21, the multilayer film 336 hasfive layers including a first layer 338 of an oriented polymer havingdirectional tear properties wherein the outer surface 335 of first layer338 will serve as the outer surface of the package. A second layer 342of adhesive is interposed between the first layer 338 and a third layer340 comprising a polymer wherein the polymer of the third layer 340 is anon-aligned polymer. The film 336 also includes a fourth layer 346comprising an adhesive interposed between the third layer 340 and afifth layer 344 comprising a polymer that may be an oriented or anon-aligned polymer. The fifth layer 344 includes a surface 337 thatwill serve as the inner surface of the package.

Referring back to FIG. 16, the high linear molecular orientations of theoriented polymer layers of the packing films that form the front andrear panels of package 300 are in parallel with tear direction T.Package 300 also includes a tear initiation element, such as tear line350, that extends from top edge 352 toward side edge 354. The tear line350 has a downward extending portion 356 that extends in the samedirection as the high linear molecular orientations of the packagingfilm. To open the package, the user grips tab 358, preferably by fingerhole 360, when one is present, and pulls downward in a direction to tearthe package along tear line 350. Tear line 350 propagates the tear in adirection parallel to the linear molecular orientation of the orientedpolymer of the front and rear panels, which panels tear along line 304(shown in phantom). Tearing along the linear molecular orientation ofthe polymer results in a substantially straight and clean tear whichresults in a substantially straight vertically extending opening.

It will be understood that FIG. 16 provides an example of one packagemade from the above discussed oriented polymer films and that such filmsmay be used in the construction of any of the packages described hereinincluding, without limitation the packages described above and shown inFIGS. 1-10, 11, and 15.

In other embodiments, the directional tear element may be a verticalscore in front and rear panels formed, for example, by laser scoring.

It will be understood that the embodiments described above areillustrative of some of the applications of the principles of thepresent subject matter. Numerous modifications may be made by thoseskilled in the art without departing from the spirit and scope of theclaimed subject matter, including those combinations of features thatare individually disclosed or claimed herein. For these reasons, thescope hereof is not limited to the above description but is as set forthin the following claims.

1. A catheter and package combination, comprising: a generallyrectangular package having opposed front and rear panels that are sealedtogether to define a sealed interior cavity, the package having top andbottom edges and opposed side edges; the cavity having a first heightextending in a direction between the top and bottom edges; the front andrear panels being configured to tear adjacent to one of the side edgesin the direction between the top and bottom edges to form an opening incommunication with the cavity, the opening having a second height in thedirection between the top and bottom edges that is smaller than thefirst height of the cavity; and a urinary catheter in a compactconfiguration disposed within the cavity.
 2. The catheter and packagecombination of claim 1 wherein the front and rear panels tear in adesired line.
 3. The catheter and package combination of claim 2 whereinthe desired line is substantially straight.
 4. The catheter and packagecombination of claim 1 further including a directional tear elementassociated with the front and rear panels for propagating the tearing offront and rear panels.
 5. The catheter and package combination of claim4 wherein the directional tear element comprises a first tear tapeoverlying an exterior surface of the front panel and a second tear tapeoverlying an exterior surface of the rear panel.
 6. The catheter andpackage combination of claim 4 wherein the directional tear elementcomprises an oriented polymer.
 7. The catheter and package combinationof claim 4 further including a tear initiation element.
 8. The catheterand package combination of claim 7 wherein the tear initiation elementcomprises a tear-line, precut-line, notch, slit, or score-line.
 9. Thecatheter and package combination of claim 7 wherein the tear initiationelement extends from the top edge to at or near the directional tearelement.
 10. The catheter and package combination of claim 1 wherein thepackage is formed from a foil.
 11. The catheter and package combinationof claim 1 wherein the package is formed from a multilayered packagingfilm.
 12. The catheter and package combination of claim 1 wherein thecatheter includes a hydrophilic coating.
 13. The catheter and packagecombination of claim 12 wherein an amount of liquid is disposed in thesealed cavity for hydrating the hydrophilic coating of the catheter. 14.The catheter and package combination of claim 13 wherein the liquidcontacts the hydrophilic coating of the catheter to hydrate thehydrophilic coating.
 15. The catheter and package combination of claim13 wherein the liquid donates a vapor that hydrates the hydrophiliccoating of the catheter.
 16. The catheter and package combination ofclaim 15 further including a wicking element containing the liquid. 17.The catheter and package combination of claim 15 further including a gaspermeable, liquid impermeable barrier disposed within the sealed cavity,the barrier dividing the sealed cavity into a first compartmentcontaining the catheter and a second compartment containing the liquid.18. The catheter and package combination of claim 1 wherein the catheteris in a coiled, curved, folded and/or bent configuration.
 19. Thecatheter and package combination of claim 1 wherein the cavity includesa first portion having the first height and a second portion having athird height in the direction between the top and bottom edges whereinthe third height is shorter than the first height.
 20. The catheter andpackage combination of claim 19 wherein the catheter in the compactconfiguration resides substantially in the first portion of the cavity.21. The catheter and package combination of claim 1 wherein the packageis sized to fit in a standard front shirt pocket and/or a standard rearpants pocket.
 22. The catheter and package combination of claim 1wherein the package has a height between about 120 mm and about 160 mmand a width between about 75 mm and about 120 mm. 23-59. (canceled) 60.The catheter and package combination of claim 1 further including acollection bag attached to the urinary catheter.